Monday marked the close of the comment period for the Food and Drug Administration’s Food Safety and Modernization Act (FSMA) rule on the Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventative Controls for Food for Animals.
The American Feed Industry Assn. said in its comments that it strongly supported development and passage of FSMA, supports and provides comments to FDA, and belongs to the Food Safety Preventive Controls Alliance’s Feed Steering Committee.
The National Grain and Feed Assn. added “the agency’s proposal would add unnecessary requirements that cause industry to direct scarce resources towards complying with regulatory obligations that will not serve to benefit the safety of animal feed and pet food.”
The over 100-page document from the National Grain and Feed Assn. and nearly 100-page comments from AFIA highlights some of their key concerns.
A major tenant of both comments focused on how FDA’s CGMPs requirements for animal feed and pet food should differ significantly from those established for human food.
“AFIA is concerned that FDA has failed to clearly delineate the human food rules from the animal food rules as Congress intended. Both the intent and sometimes the language used in the statute require a separation of the rules,” their comments said. “FDA has created separate rules physically, but they are both philosophically driven by a human food approach, using language such as ‘sanitary’ and ‘hand-washing’ and ‘utensils.’”
The NGFA opposes the repeated use of the term “contamination” throughout the proposed regulation. Their comments said as FDA is aware, the term “contamination” is not defined and has no legal meaning. “We strongly believe that FDA’s regulation cannot rightfully focus on avoiding and preventing ‘contamination,’ when that term has no defined meaning in a regulatory context. As such, we urge FDA to replace the term ‘contamination’ throughout its proposed regulation with the term ‘adulteration.’”
Many of the provisions look similar to HACCP (Hazard Analysis Critical Control Points), but this is not supposed to be a HACCP law, which the groups also clarified.
“While the NGFA supports the use of prudent, appropriate and risk-based practices to assure the safety of animal feed and pet food, we strongly believe that FDA’s proposed preventive controls regulation clearly is not aligned with the intent of Congress when the agency was provided authority under FSMA to promulgate hazard analysis and preventive controls requirements,” their comments said. “Clearly, the statutory language within FSMA does not mandate that covered animal feed and pet food facilities implement regulatory HACCP plans. Had Congress intended to provide FDA the authority to promulgate formal HACCP regulations through FSMA, it plainly could have done so within the statutory language it crafted.”
AFIA also said it is concerned about the reference regarding employee’s illnesses beingtransmitted to animals via handling of the animal food by such employees. Their comments cited Dr. Tim Goldsmith, Center for Animal Health and Food Safety, University of Minnesota, who determined that the scientific literature has not documented such transmission, and it is unlikely.
Another similarity between the comments is a request to adjust compliance dates to phase in CGMP’s first and then the preventative control rules. The two groups urged FDA to adopt one year for businesses other than small and very small businesses; 2) two years for small businesses; and 3) three years for very small businesses, respectively for CGMPs and two, three and four-year, respectively for the preventive controls.